FI3237001T3 - Il-17-vasta-aineiden farmaseuttisia tuotteita ja stabiileja nestemäisiä koostumuksia - Google Patents

Il-17-vasta-aineiden farmaseuttisia tuotteita ja stabiileja nestemäisiä koostumuksia Download PDF

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Publication number
FI3237001T3
FI3237001T3 FIEP15823805.5T FI15823805T FI3237001T3 FI 3237001 T3 FI3237001 T3 FI 3237001T3 FI 15823805 T FI15823805 T FI 15823805T FI 3237001 T3 FI3237001 T3 FI 3237001T3
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FI
Finland
Prior art keywords
secukinumab
less
methionine
composition
polysorbate
Prior art date
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FIEP15823805.5T
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English (en)
Finnish (fi)
Inventor
Susanne Joerg
Kathrin Serno-Schersch
Original Assignee
Novartis Ag
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Publication of FI3237001T3 publication Critical patent/FI3237001T3/fi

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Rheumatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Transplantation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
FIEP15823805.5T 2014-12-22 2015-12-21 Il-17-vasta-aineiden farmaseuttisia tuotteita ja stabiileja nestemäisiä koostumuksia FI3237001T3 (fi)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201462095210P 2014-12-22 2014-12-22
PCT/IB2015/059836 WO2016103153A1 (en) 2014-12-22 2015-12-21 Pharmaceutical products and stable liquid compositions of il-17 antibodies

Publications (1)

Publication Number Publication Date
FI3237001T3 true FI3237001T3 (fi) 2024-03-22

Family

ID=55135471

Family Applications (1)

Application Number Title Priority Date Filing Date
FIEP15823805.5T FI3237001T3 (fi) 2014-12-22 2015-12-21 Il-17-vasta-aineiden farmaseuttisia tuotteita ja stabiileja nestemäisiä koostumuksia

Country Status (29)

Country Link
US (2) US11801300B2 (he)
EP (2) EP3237001B1 (he)
JP (4) JP6770974B2 (he)
KR (3) KR102614921B1 (he)
CN (5) CN114452380A (he)
AR (1) AR103173A1 (he)
AU (1) AU2015370522B2 (he)
BR (1) BR112017013240A2 (he)
CA (1) CA2971800A1 (he)
CL (1) CL2017001638A1 (he)
CO (1) CO2017005950A2 (he)
DK (1) DK3237001T3 (he)
EA (1) EA033824B1 (he)
EC (1) ECSP17047155A (he)
FI (1) FI3237001T3 (he)
HR (1) HRP20240253T1 (he)
IL (3) IL310604A (he)
LT (1) LT3237001T (he)
MX (1) MX2017008412A (he)
PE (1) PE20170952A1 (he)
PH (1) PH12017500966A1 (he)
PL (1) PL3237001T3 (he)
PT (1) PT3237001T (he)
RS (1) RS65387B1 (he)
SG (1) SG11201703828VA (he)
SI (1) SI3237001T1 (he)
TN (1) TN2017000181A1 (he)
TW (1) TW201641104A (he)
WO (1) WO2016103153A1 (he)

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AR103172A1 (es) * 2014-12-22 2017-04-19 Novartis Ag Reducción selectiva de residuos de cisteina en anticuerpos il-17
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CN112915201B (zh) * 2019-12-06 2023-06-27 珠海市丽珠单抗生物技术有限公司 包含抗il-17抗体的液体制剂
WO2022258045A1 (zh) * 2021-06-11 2022-12-15 山东先声生物制药有限公司 抗人il-17抗体和taci的双功能融合蛋白分子
CN113999300B (zh) * 2021-12-13 2022-09-13 青岛润达生物科技有限公司 一种高效提取卵黄抗体的复合沉降剂及方法
CN114452383B (zh) * 2022-02-17 2023-06-06 中国中医科学院中药研究所 司库奇尤单抗在治疗糖尿病溃疡中的用途
CN117883376B (zh) * 2024-03-14 2024-06-25 北京四环生物制药有限公司 含重组人白细胞介素-2的药物制剂及其制备方法

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Also Published As

Publication number Publication date
CA2971800A1 (en) 2016-06-30
JP6770974B2 (ja) 2020-10-21
PL3237001T3 (pl) 2024-06-24
WO2016103153A1 (en) 2016-06-30
CL2017001638A1 (es) 2018-04-13
IL310604A (he) 2024-04-01
DK3237001T3 (da) 2024-04-15
KR20230173742A (ko) 2023-12-27
US20240173404A1 (en) 2024-05-30
CN114452380A (zh) 2022-05-10
JP2018502910A (ja) 2018-02-01
AU2015370522B2 (en) 2018-05-10
JP2021119165A (ja) 2021-08-12
EP3237001B1 (en) 2024-02-07
ECSP17047155A (es) 2019-02-28
KR20170095878A (ko) 2017-08-23
CN113876947A (zh) 2022-01-04
JP6878524B2 (ja) 2021-05-26
CN113855800A (zh) 2021-12-31
HRP20240253T1 (hr) 2024-05-10
SI3237001T1 (sl) 2024-06-28
RS65387B1 (sr) 2024-04-30
JP2020011963A (ja) 2020-01-23
TN2017000181A1 (en) 2018-10-19
PE20170952A1 (es) 2017-07-13
EP4372005A3 (en) 2024-07-31
IL287328A (he) 2021-12-01
CN107257692A (zh) 2017-10-17
EP4372005A2 (en) 2024-05-22
EA201791422A1 (ru) 2017-10-31
US11801300B2 (en) 2023-10-31
IL252141B (he) 2021-12-01
KR20230037677A (ko) 2023-03-16
IL287328B2 (he) 2024-07-01
AR103173A1 (es) 2017-04-19
PH12017500966A1 (en) 2017-10-18
CO2017005950A2 (es) 2017-08-31
KR102506173B1 (ko) 2023-03-07
EP3237001A1 (en) 2017-11-01
CN114452381A (zh) 2022-05-10
KR102614921B1 (ko) 2023-12-19
SG11201703828VA (en) 2017-07-28
EA033824B1 (ru) 2019-11-29
IL287328B1 (he) 2024-03-01
CN107257692B (zh) 2021-11-19
LT3237001T (lt) 2024-04-25
MX2017008412A (es) 2017-10-19
US20170368174A1 (en) 2017-12-28
AU2015370522A1 (en) 2017-06-01
JP2023113906A (ja) 2023-08-16
BR112017013240A2 (pt) 2018-02-06
TW201641104A (zh) 2016-12-01
PT3237001T (pt) 2024-04-16
IL252141A0 (he) 2017-07-31

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